Mechanical Engineer
11085 Knott Ave. , Suite B Cypress, CA 90630 US
Job Description
Contract, 6 Months
Hybrid Schedule
Pay Rate: $55/hr
What We Need to See
- B.S. in Mechanical Engineering or related field; advanced degree a plus.
- At least 2 years of experience in mechanical engineering within the medical device or regulated industry, manufacturing support a plus.
- Proficiency in design software (e.g., SolidWorks) and engineering documentation systems (PLM).
- Demonstrated experience Geometric Dimensioning & Tolerancing (GD&T) and tolerance stack-up analysis (device hardware).
- Strong knowledge of FDA regulations, ISO 13485, and design control principles.
- Demonstrated experience with root cause analysis, risk management, and problem-solving methodologies.
- Understanding printed circuit board (PCB) design and integration with mechanical interfaces used in medical devices a plus.
- Ability to collaborate with manufacturing and quality teams to troubleshoot production issues and implement continuous improvement.
- Basic understanding of manufacturing processes such as injection molding, machining, and assembly.
- Familiarity with Six Sigma, Lean Manufacturing, or other continuous improvement methodologies.
- Understanding of biocompatibility, materials science, including polymers and metals used in medical devices a plus.
- Basic understanding of ERP systems and manufacturing execution systems (MES) a plus
Job Description
Medical device manufacturing company in Cypress is seeking skilled a Mechanical Engineer to join our Lifecycle (Sustaining) Engineering team. This role focuses on supporting existing products through their lifecycle, ensuring quality, compliance, and continuous improvement while maintaining business continuity. In this role, you will have the opportunity to lead cross-functional projects that keep released medical device products compliant, reliable, cost-effective, and continuously manufacturable. You'll play a pivotal role within quality functions, charting the course for the company's capabilities, and collaborating with cross-functional teams.
What You WIll Be Doing
- Provide mechanical engineering & design support for sustaining activities, including, fixture mechanical design, component/material changes, and process improvements for existing products.
- Investigate and resolve product performance issues, manufacturing challenges, and field complaints through root cause analysis and corrective actions.
- Collaborate with cross-functional teams (Quality, Regulatory, Manufacturing, and Supply Chain) ensuring compliance with FDA, ISO 13485, ISO 10993, and other applicable standards.
- Evaluate and qualify alternate components (mechanical/electrical), materials or suppliers to mitigate obsolescence and supply chain risks without compromising product quality or regulatory compliance.
- Create and maintain engineering documentation within PLM system, including drawings, specifications, and change orders, in accordance with design control requirements from development through production.
- Author and execute V&V test plans, protocols, and reports compliant with applicable IEC standards and internal SOPs.
- Participate in risk management activities, including FMEA updates and hazard analysis for design changes.
- Provide technical input for process validation, equipment qualification, and manufacturing transfer activities.
- Serve as a subject matter expert for mechanical design and manufacturing processes within the lifecycle engineering team.
Work Environment / Other Requirements:
- Cypress, CA Onsite (Hybrid)
#MS-OCENG
Meet Your Recruiter
Kyle Webb
Recruiter
Since joining Marquee Staffing in 2022, Kyle has played an integral role in supporting recruitment efforts across a diverse range of industries, including accounting, finance, procurement, manufacturing, design, and IT. He is passionate about connecting the right talent with the right opportunities and is skilled in understanding both client expectations and candidate goals.
Kyle takes a thoughtful, people-first approach—carefully assessing each applicant’s skill set and career aspirations to ensure the best possible fit. He prides himself on helping candidates take the next step in their career journey while meeting the evolving needs of Marquee’s clients.
Before launching his career in recruiting, Kyle spent six years in the service industry as a barista and waiter, where he developed his strong communication and interpersonal skills. He holds a Bachelor's degree in Psychology from California State University, Long Beach.
Outside of work, Kyle enjoys playing card games and building model kits.